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临床试验/CTRI/2024/02/062241
CTRI/2024/02/062241尚未招募不适用

A Randomized Control Trial on effect of Halotherapy in improving airway clearance among patient with COPD admitted in selected tertiary care hospital of Western Maharashtra.

Dr Manu Chopra1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年3月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
200
试验地点
1
主要终点
improvement in breathing pattern

研究概览

简要总结

Hypertonic saline nebulization therapy Procedure:  Random sampling of patients will be done. On admission mortality assessment will be done by DECAF score. Sample will be equally divided into 2 groups (Intermediate & High risk).  Random sampling will be done to devide them in experimental and control grop.Experimental group will be administered 3% hypertonic saline nebulisation after routine broncodilator neblisation for 10 mins 6 hrly in a day for 07 days and control group will receive routine broncodilator neblisation treatment of exacerbation of COPD. Both groups will have control and experimental group. Groups will be assessed by modified borg scale, peak flow, duration of hospital stay, need of invasive ventilation & 30 day mortality with Spirometry, pulse oximetry, heart rate recording & respiratory rate recording to ensure the evidence of bronchospasm. Both the pre intervention and post intervention scores will be entered in coding sheet.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
16.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • All patients previously diagnosed with COPD and presently admitted with acute exacerbation having intermediate to high risk as per DECAF score.

排除标准

  • Patients with history of hospitalization in last 90 days.
  • Patients requiring invasive mechanical ventilation within 48 hours of hospitalization.
  • Patient with asthma COPD overlap and COPD bronchiectasis overlap.
  • • Non- consenting patients • Patient allergic to Sodium Chloride.
  • • Patient geting other mucoactive substance other than standard treatment.

结局指标

主要结局

improvement in breathing pattern

时间窗: after 7 days therapy

Improvement in peak flow

时间窗: after 7 days therapy

次要结局

未报告次要终点

研究者

发起方
Dr Manu Chopra
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

TULIKA DE BISWAS

College of Nursing, Armed Forces medical College & Hospital

研究点 (1)

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